Lens, Multifocal Intraocular

Basic Information

• Device Name: Lens, Multifocal Intraocular
• Trade Name: ACRYSOF IQ RESTOR APODIZED + 3.0D MULTIFOCAL TORIC INTRAOCULAR LENS
• PMA Number: P040020
• Supplement Number: S068
• Device Class: FDA Class 3
• Product Code: MFK
• Generic Name: Lens, multifocal intraocular
• Regulation Number: 886.3600
• Medical Specialty: Ophthalmic
• Advisory Committee: Ophthalmic
• Decision: Approved
• Decision Code: APPR
• Decision Date: October 11, 2018
• Date Received: January 23, 2017
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol
• Expedited Review: N

Advisory Committee Statement

Approval of the protocol for the post-approval protocol for the post-approval study (PAS) protocol.

Classifications

This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

Product Code	Device Name	Device Class	Medical Specialty
MFK	Lens, Multifocal Intraocular	FDA class 3	Ophthalmic

Applicant

• Name: Alcon Research, Ltd.
• Address: 6201 South Freeway, Fort Worth, TX, 76134, 2099